Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen

Sponsor

Majianhua (Other)

Overall Status

Unknown status

CT.gov ID

NCT04074603

Collaborator

(none)

1,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To comparing the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Device: The needle-free jet injector Device: Conventional insulin pen	Phase 4

Detailed Description

Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile and safety in type 2 diabetic patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparing the Effects of Insulin Glargine on Peripheral Blood Glucose Between Needle-free Jet Injection and Conventional Insulin Pen

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A needle-free before needle	Device: The needle-free jet injector Continuous insulin therapy for 2 weeks
Experimental: Group B needlebefore needle-free	Device: Conventional insulin pen Continuous insulin therapy for 2 weeks

Arm

Intervention/Treatment

Experimental: Group A

needle-free before needle

Device: The needle-free jet injector

Continuous insulin therapy for 2 weeks

Experimental: Group B

needlebefore needle-free

Device: Conventional insulin pen

Continuous insulin therapy for 2 weeks

Outcome Measures

Primary Outcome Measures

Blood glucose profile [2 weeks]
changes of blood glucose profile

Secondary Outcome Measures

Sensitivity Questionnaire of Patients [2 weeks]
changes of Sensitivity Questionnaire of Patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

volunteer to participate and be able to sign informed consent prior to the trial.
patients with type 2 diabetes, aged 18-80 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (4-35 units) combined with oral medicationis, stable for more than 2 months.
No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

Patients with insulin allergy.
Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
Drug abuse and alcohol dependence in the past 5 years.
Systemic hormone therapy was used in the last three months.
Patients with poor compliance and irregular diet and exercise.
Patients with pregnancy, lactation or pregnancy intention.
Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Majianhua

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Majianhua, Director, Head of Endocrinology department, Clinical Professor, Nanjing First Hospital, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04074603

Other Study ID Numbers:

KY20190530-02-KS-01

First Posted:

Aug 30, 2019

Last Update Posted:

Aug 30, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Majianhua, Director, Head of Endocrinology department, Clinical Professor, Nanjing First Hospital, Nanjing Medical University

Needle-free jet injection

Insulin glargine

Additional relevant MeSH terms:

Insulin

Study Results

No Results Posted as of Aug 30, 2019